Quality Manager R&D
Pharmaceutical Product Development
MO

Great Management Opportunity with Global Pharmaceutical Leader!

Quality Manager R&D- Solid Dosage Pharmaceutical Development
This person will providemanagement of R&D Quality activities for a large solid dosage pharmaceutical company including product development, analytical development, maintenance of business activities, and ensure that R&D activities fulfill regulatory agency requirements for adequacy of documentation.

This person will also establish strategic and tactical plans to support the fulfillment of product pipeline development relating to quality, compliance, and execution. Establish standardized procedures and manage quality and compliance related product transfer activities from R&D to the commercial quality function.  Manage quality activities, such as audits, monitoring, remediation, inspection preparation, and data integrity, for clinical operations. Manage Quality functional support of the Product Development Process (PDP).  Provide customer technical and/or quality support as it relates to new or existing products as necessary.

Requirements Education and Experience
• Minimum BS in Chemistry, Chemical Engineering, Pharmacy, or related science (advanced degree preferred)
• Minimum 10 years overall experience in pharmaceutical R&D roles with at least 5 years in a R&D quality management role. This experience must include development of solid dosage products. And experience (2 – 4 years minimum) managing diverse quality organizations, such as quality control, quality assurance, validation, documentation, etc.
• Direct experience in R&D activities associated with development of CMC NDA/ANDA submissions, FDA Pre-Approval Inspections, and product approvals
• Expert knowledge and experience in cGMP systems
• Certification as Certified Quality Engineer, Six Sigma Black Belt, or Lean preferred
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